NCT02732119|CompletedPhase 1ResultsDMC

Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

TRINITI-1

A Phase I/II, Single Arm, Open-label Study of Ribociclib in Combination With Everolimus + Exemestane in the Treatment of Men and Postmenopausal Women With HR+, HER2- Locally Advanced or Metastatic Breast Cancer Following Progression on a CDK 4/6 Inhibitor

Novartis Pharmaceuticals ClinicalTrials.gov

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1 other identifier

CLEE011XUS29

Study Type

interventional

Target

104

Locations

1 country

Sites

Timeline

RegisteredApr 2016

StartedJun 2016

CompletionFeb 2020

Brief Summary

The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

104

participants targeted

Target at P75+ for phase_1 breast-cancer

Timeline

Completed

Started Jun 2016

Geographic Reach

1 country

25 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

First Submitted

Initial submission to the registry

April 4, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

April 8, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

June 14, 2016

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2020

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

May 5, 2021

Completed

Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

3.7 years

First QC Date

April 4, 2016

Results QC Date

February 22, 2021

Last Update Submit

April 10, 2021

Conditions

Breast Cancer

Keywords

HR-positiveHER2-negativeAdvanced breast cancerLEE011ribociclibeverolimusAfinitorexemestaneAromasinCDKCDK4CDK6CDK4/6CDK4/6 inhibitorPhase IPhase IIER-positivePR-positivePostmenopausaladult

Outcome Measures

Primary Outcomes (3)

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I
A dose-limiting toxicity (DLT) is defined as an adverse event or abnormal laboratory value assessed as having a reasonably possible relationship to the study medication(s) and is unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment (cycle 1) and meets any of the criteria defined in the protocol. National Cancer Institute Common Terminology Criteria for Adverse events (NCI CTCAE) version 4.03 will be used for all grading.
Baseline up to 28 days
Clinical Benefit Rate as Per Central Review by Group- Phase II
Clinical Benefit Rate (CBR) is defined as the percentage of participants with a complete response (CR) or partial response (PR) or with stable disease (SD) as per Response Evaluation Criteria in Solid Tumors (RECIST) V1.1 or Non-Complete Response or Non-Progressive Disease (NCRNPD) during first 24 weeks of first dose. CR=disappearance of all non-nodal target lesions, PR=at least a 30% decrease in the sum of diameter of all target lesions, SD=neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease (PD), PD=at least a 20% increase in the sum of diameter of all target lesions. The hypothesis was to be rejected if the lower limit of the 95% Confidence Interval for Clinical Benefit Rate (CBR) was greater than 10%.
From baseline up to 24 weeks
Best Overall Responses (BOR) Summary Table as Per Central Review by Group - Phase II
Complete response (CR) or partial response (PR), or stable disease (SD) at 24 weeks as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Non-CR Non-PD (NCRNPD) at Week 24.
Baseline up to 24 weeks and at 24 weeks

Secondary Outcomes (8)

Everolimus Pharmacokinetic Plasma Concentrations by Cohort - Phase I
Cycle 1,2: Day 1 and 15 - pre-dose, 2 and 4 hour post dose, Cycle 3 , Day 1 - pre-dose
Best Overall Responses (BOR) Summary Table as Per Central Review by Cohort - Phase I
From baseline up to 24 weeks
Clinical Benefit Rate as Per Central Review by Dose Cohort - Phase I
Baseline up to 24 weeks and at week 24
Summary of Progression-free Survival (PFS) (Months), as Per Central Review by Group - Phase II
Baseline up to approximately 32 months
Overall Survival (OS) by Group - Phase II
Baseline up to approximately 32 months
+3 more secondary outcomes

Study Arms (5)

Cohort A

EXPERIMENTAL

Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B